There are approximately 500,000 to 800,000 needle stick injuries reported each year regarding healthcare professionals in the United States. Other than in the patient's room, these accidents occur most often in the operating room. As a result of this significant health hazard, health device manufacturers have developed various products designed to protect healthcare professionals. These items include retractable syringes, “sharps” containers, syringe covers, syringe guards, etc. While needle sticks associated with syringes account for an estimated 75% of the problem, it is estimated that most of the remaining 25% are the result of sticks associated with suturing during surgical procedures or during the unprotected passing of these sharps. It is this niche which has not been adequately adressed by suture manufacturers who have left it up to the discretion of the end user to provide their own protection.
The Occupational Safety & Health Administration (OSHA) in directive #CPL2-2.44D, issued Nov. 5, 1999 mandated a change in the Federal Blood Borne Pathogens Act. They called for a shift in work practice controls and issued a call for engineering solutions for use when sharps are passed from one individual to another. The Act states, “The employer must use engineering and work practice controls to eliminate occupational exposure or reduce it to the lowest feasible extent.” Further, they specifically called for the elimination of “hand-to-hand” or direct passing of all sharps. The overall goal is to reduce the risk of accidental needle or scalpel injuries during this process.
Additionally, they issued four engineering design requirements which include:
(1) A thick safety feature that provides a barrier between the hands and needle after use. The safety feature should allow or require the worker's hands to remain behind the needle at all times;
(2) The safety feature is an integral part of the device and not an accessory;
(3) The safety feature is in effect before disassembly and remains in effect after disposal to protect users and trash handlers; and
(4) The safety feature is as simple as possible, requiring little or no training to use effectively.
The apparatus of the present invention is designed to meet all of OSHA's design requirements while remaining user friendly and without the incorporation of new hand movements during an operation. It is compact, hand-held, and functions for both suture needles of all sizes as well as scalpels. Additionally, it functions as a safe return device (i.e., passing of sharps occurs in two directions). Moreover, it acts as a counting device for needles and also functions as a temporary storage and/or disposable container for used suture needles and scalpels. Known efforts to date have been focused on prevention of syringe needle sticks with retractable syringes. Simple guard type devices are also available for some scalpels. No other multi-functional yet simple device for use with suture needles and scalpels that also satisfies the new OSHA requirements is known.
The Prior Art fails to recognize the value in coupling slots for use with sharp implements which effectively immobilize the sharp implement for transfer purposes, coupled with a magnetically enhanced disposal compartment for easy counting and disposal. By using the novel design of the present invention, coupled with the new system arrangement of the essential elements of the invention, a more flexible configuration is shown which overcomes the inherent limitations of the teachings of the Prior Art as well as permitting a wider range of applications, not permitted with the presently available systems.